By Sean Fenske, Editor-in-Chief
 
Nitinol is already a preferred material for a number of medical devices. From guidewires to orthopedic technologies, it provides benefits that make it attractive to multiple types of manufacturers. These same advantages, however, are also the reason the increasing demand is making it more challenging to source.
 
Given these concerns and with more applications coming that will require the material in the future, it’s critical to identify reliable suppliers who can ensure a steady flow. Further, it’s important to find those partners who have experience with Nitinol for applications in the medical device space. This combination is not common within the medtech supply chain.
 
Fortunately, Confluent Medical Technologies is such a supplier, as it’s made significant investments in its Nitinol supply sources and also boasts a long history as a component supplier of the material. Addressing questions on its expertise and what medical device companies can expect for Nitinol in the future is Confluent’s Sr. Director Product Development, Tom Ditter. In the following Q&A, he tackles several topics such as where Nitinol is used currently, where it is likely to be used in the future, and what concerns are related to its supply.
 
Sean Fenske: What are the current applications of Nitinol in medical devices?
 
Tom Ditter: Unique super-elastic and shape-memory properties make Nitinol vital to the medical device industry, with life-saving applications in cardiovascular, neurovascular, and peripheral vascular devices. Some specific applications include a variety of cardiovascular and neurovascular stents and stent grafts, heart valve frames, embolic protection filters, guidewires, orthopedic bone staples and implants, and surgical instruments. High purity Nitinol, such as Confluent’s ELI material, is an ideal alloy for high cycle fatigue applications such as cardiovascular implants or components with small features such as neurovascular stents.
 
Fenske: Some have demonstrated concern about Nitinol’s availability. What have you done to ensure a reliable supply chain of the material?
 
Ditter: The demand for Nitinol has increased drastically over recent years but because of complex production issues and limited melters, the industry is experiencing a supply chain gap. Confluent recognized this gap early on and has invested over $100 million across multiple stages of the Nitinol supply chain. Specifically, we recently invested over $50 million in Nitinol melt and materials conversion infrastructure with our materials-producing partner, ATI. This has significantly increased the current Nitinol melt capacity for medical device applications. These investments allow Confluent to guarantee material to our customers for their Nitinol components with industry-leading lead times.
 
Fenske: What capabilities are required to manipulate Nitinol in ways required by medical device manufacturers?
 
Ditter: Confluent’s vast history with Nitinol goes back to our founding as NDC—Nitinol Device and Components. For over 30 years, our experts have been setting the standards for Nitinol manufacturing. The key capabilities required to provide finished Nitinol components start with material expertise and design collaboration, advanced precision laser cutting, heat treatment and shape setting, and surface finishing and electropolishing.
 
Beyond just the manufacturing capabilities, it is critical to have a strong supply chain to support the latest metrology technologies. Confluent is continuing to expand its vertical integration supply chain for Nitinol material to develop next-generation, high purity Nitinol that enables a lower profile and more during implants for the medical device manufacturer.
 
Fenske: Can you provide a real-world example of these capabilities being used for a medical device success story?
 
Ditter: Confluent offers material science expertise to assist our OEM customers in the development and design of their device. One example of this is when we were working with a customer on a next-generation neurovascular stent. This stent was designed for intracranial atherosclerotic disease. Confluent produced tubing within the required tolerances utilizing our low-inclusion Nitinol alloy. Despite challenging dimensional requirements due to the small size of many of the stent features, our team of experts was able to laser cut, post-process, and, most importantly, inspect the parts, resulting in a successful component for our customer.
 
Fenske: What challenges still need to be overcome to move Nitinol forward for future applications?
 
Ditter: The recent growth in popularity represents the vast applications of this unique alloy. However, there are still challenges the medical device industry faces to fully unlock Nitinol’s potential. An example of one of these challenges is within interventional medical devices. The demand for minimally invasive procedures means these devices continue to get smaller and are indicated for increasingly challenging anatomy. The ability to manufacture high-purity Nitinol material (wire, tubing, sheet) with small nominal dimensions and tight tolerances will be a continuing challenge moving forward.
 
Fenske: What do you foresee as those future applications? Where will Nitinol be used within medical device manufacturing?
 
Ditter: As mentioned previously, the demand for minimally invasive procedures is growing so we can expect to see Nitinol as a key alloy for these devices. Future applications include neurovascular, ophthalmologic, and structural heart devices with an emphasis on profile and durability. Additionally, higher purity Nitinol is needed to address high-fatigue applications to prevent fracturing and improve longevity for the patients.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
 
Ditter: The unique properties of Nitinol make it ideal for use in many interventional medical devices. By understanding the science and technology of Nitinol and its processing, medical device manufacturers can better utilize this alloy across different applications. However, manufacturers also need to understand the full scope of their Nitinol supply chain. If a component manufacturer is unable to guarantee material, then there will be production delays. Investing in a strong team of material science experts with a robust vertically integrated supply chain will allow you to deliver world-class medical devices for years to come.
 
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